Neurocrine Biosciences, a San Diego-based biopharmaceutical company focused on neurological and endocrine diseases, has entered into an exclusive licensing agreement with Bial, a Trofa, Portugal-headquartered pharmaceutical company, to develop and commercialize opicapone, the active ingredient in Bial’s Parkinson’s disease drug, Ongentys (opicapone), in North America.

Ongentys was approved in June 2016 in Europe by the European Commission as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for treating adults with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. The drug is not approved for use in the US or Canada.

Under the agreement, Neurocrine will develop and commercialize opicapone in the US and Canada and will make an upfront payment of $30 million to Bial. Neurocrine will also fund all development activities necessary for US Food and Drug Administration (FDA) approval. Bial is eligible to receive additional milestone payments of approximately $115 million from Neurocrine for the achievement of certain development, regulatory, and commercial milestones. In addition, Neurocrine will pay Bial a percentage of net sales in exchange for the manufacture and supply of opicapone drug product.

Upon the completion of technology transfer from Bial, Neurocrine intends to meet with the FDA to discuss a potential new drug application submission.

Opicapone is a once-daily, peripherally acting, highly selective catechol-O-methyl transferase (COMT) inhibitor, which prolongs the duration of levodopa’s effect, according to Neurocrine. The drug was discovered by Bial and is designed to provide a treatment option without the side-effects and complicated dosing regimen of other COMT inhibitors.

Source: Neurocrine Biosciences